BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8422934 · Received March 14, 2019

    Report

    Report Number
    3006630150-2019-01060
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 22, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 20808266 /5082831; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING THE MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WERE FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO WOUND DEHISCENCE AT THE INCISION SITE AND IMPAIRED HEALING. THE PHYSICIAN BELIEVED THE PATIENT'S WOUND DID NOT HEAL PROPERLY FROM THE PREVIOUS IMPLANT. THE PATIENT HAD WOUND CARE AND ANTIBIOTICS WERE GIVEN. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213869 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 338101 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention